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Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork R...

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Department of Health and Human Services
Food and Drug Administration
  1. [Docket Nos. FDA-2013-N-0134; FDA-2016-D-2565; FDA-2013-N-0514; FDA-2015-N-0030; FDA-2021-N-0584; FDA-2021-N-1026; FDA-2013-N-0557; FDA-2014-N-0053; FDA-2013-N-0190; FDA-2019-N-0305; FDA-2019-N-2854; FDA-2019-N-5553; FDA-2017-D-0085; FDA-2016-N-2544; FDA-2019-N-2778; FDA-2012-N-0977; FDA-2010-D-0319; and FDA-2018-N-3728]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of ( printed page 9522) Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, .

SUPPLEMENTARY INFORMATION:

The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/​public/​do/​PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

Table 1—List of Information Collections Approved by OMB
Title of collection OMB control No. Date approval expires
Mammography Standards Quality Act Requirements 0910-0309 11/30/2025
510(k) Third-Party Review Program 0910-0375 11/30/2025
Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization 0910-0607 11/30/2025
Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act 0910-0800 11/30/2025
Pilot to Develop Standardized Reporting Forms for Federally Funded Public Health Projects and Agreements 0910-0909 11/30/2025
Text Analysis of Proprietary Drug Name Interpretations 0910-0910 11/30/2025
Postmarket Surveillance of Medical Devices 0910-0449 12/31/2025
Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods 0910-0560 12/31/2025
Warning Plans for Smokeless Tobacco Products 0910-0671 12/31/2025
Deeming Tobacco Products To Be Subject to the FD&C Act 0910-0768 12/31/2025
Premarket Tobacco Product Applications and Recordkeeping Requirements 0910-0879 12/31/2025
Right to Try Act: Reporting Requirements 0910-0893 12/31/2025
Substances Generally Recognized as Safe: Best Practices for Convening a GRAS Panel 0910-0911 12/31/2025
Medical Devices—Quality System Regulation; 21 CFR part 820 0910-0073 1/31/2026
Threshold of Regulation for Substances Used in Food-Contact Articles 0910-0298 1/31/2026
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents 0910-0312 1/31/2026
Mailing of Important Information About Drugs 0910-0754 1/31/2026
Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs 0910-0882 1/31/2026

Dated: February 8, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2023-03073 Filed 2-13-23; 8:45 am]

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88 FR 9521

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“Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,” thefederalregister.org (February 14, 2023), https://thefederalregister.org/documents/2023-03073/agency-information-collection-activities-announcement-of-office-of-management-and-budget-approvals.